Research & Development
Bristol Myers Squibb receives positive CHMP opinion for Opdivo with chemotherapy in neoadjuvant treatment of resectable NSCLC
26 May 2023 -

Biopharmaceutical company Bristol Myers Squibb (NYSE:BMY) announced on Friday that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Opdivo (nivolumab) in combination with chemotherapy for neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in patients with tumour cell PD-L1 expression ≥1%.

This recommendation was based on Phase 3 CheckMate -816 trial results, showing improved event-free survival and pathologic complete response compared to chemotherapy alone when given before surgery.

If approved, Opdivo with chemotherapy would be the first neoadjuvant immunotherapy-based option for NSCLC patients in the European Union.

The CHMP recommendation will now be reviewed by the European Commission.

Opdivo has already been approved for neoadjuvant treatment of resectable NSCLC in multiple countries, including the United States, Japan and China. Opdivo-based treatments have demonstrated efficacy in neoadjuvant or adjuvant treatment of lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.